Reinforced closure anchor

ABSTRACT

A reinforced closure anchor includes a first layer having an adhesive side, an opposite non-adhesive side, and an outer edge. An anchor member layer having a reinforcing structure is disposed on the first layer. The anchor member includes an adhesive side and an opposite non-adhesive side. The anchor member adhesive side is adhered to the first layer non-adhesive side or the first layer adhesive side. The anchor member may be generally centered between ends of the first layer, the anchor member may extend to portions of the outer edge of the first layer, and the anchor member may have a shape that generally corresponds in shape to a middle portion of the first layer.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/690,315, filed Jan. 20, 2010, which is a continuation-in-part of U.S.patent application Ser. No. 12/558,634, filed Sep. 14, 2009, which is acontinuation of U.S. patent application Ser. No. 12/011,692, filed Jan.29, 2008.

TECHNICAL FIELD

This invention relates to medical dressings, and more particularly toreinforced closure members for closing a portion of a medical dressingand anchoring medical tubing.

BACKGROUND OF THE INVENTION

It is known in the art relating to medical dressings for the protectionand securement of catheters to apply a dressing to a patient's skin tocover a catheter insertion site at which the catheter punctures apatient's skin. It is also common for medical clinicians (i.e., doctors,nurses, and other medical personnel) to alternatively or additionallyapply strips of medical grade tape to attempt to secure the catheter orassociated medical tubing. Another conventional clinical practice is tosuture a catheter hub to a patient's skin to invasively and roughlysecure the catheter to the patient. Further still, a variety of catheterand medical tubing securement devices are available for use in themedical field. These securement devices, however, are often bulky andcumbersome, hard to dress and/or remove with a dressing, may require ascissors or scalpel to physically cut them away risking catheter lumenor catheter pigtails damage in the process, may require two, three, orfour pieces of tape to get reliable results, and may have costly andcomplex mechanical features; all of which can combine to both lowerpatient care clinical outcomes, and equally important, lead to higherhealthcare costs due to added nursing costs.

It is also known in the medical field that poorly dressed and poorlysecured catheters and associated tubing are likely to undesirably leadto irritation of both internal vascular wall damage at distal cathetertip due to in/out catheter tip motion at the insertion site,necessitating premature rotation and reinsertion of the catheter to anearby new anatomical insertion site. Even worse, poorly securedcatheters are susceptible to accidental dislodgement from the insertionsite. For example, medical tubing connected to indwelling catheters,infusion needles and the like is often subjected to inadvertent butsignificant pulling forces either caused directly by patient movement orby snagging of the tubing on other objects. These pulling forces peelthe medical tape or dressing securing the catheter and/or tubing off thepatient's skin. This exposes the catheter, infusion needle, etc. tomovement inward or outward, increasing the likelihood that the catheter,infusion needle, etc. will fail and have to be replaced and insertedinto a new insertion site. Also, this may weaken the adhesion betweenthe dressing and the patient's skin, potentially exposing the insertionsite to harmful bacteria.

SUMMARY OF THE INVENTION

The present invention provides a reinforced closure anchor that canclose over and anchor a slit, perforation, notch, or edge portion of amedical dressing at which a catheter and/or tubing exits from underneaththe dressing. The reinforced closure anchor helps prevent a dressingfrom inadvertently peeling from a patient's skin, which may be caused bytugging on tubing that is under and exiting from the dressing, by bothcovering over a portion of the medical dressing and by securing an areaof the dressing at which medical tubing exits from underneath thedressing. The reinforced closure anchor also prevents inadvertentpeeling by providing additional material beyond the dressing edge,thereby greatly multiplying the dressing withstand in tug force vectordirections opposite to (and at any relative angle to, over an entirehemispherical (half globe) field of tug force vectors) that which tubingexits from the dressing. Also, the reinforced closure anchor limits theamount of fabric cloth stretching that can occur by using relativelynon-elastic reinforcement material for a spinal structure, which limitsthe amount and size of a “hole” that can be stretched open by tugs, andthus prevents catheter hubs and/or tubing from “oozing” out of adressing. And due to the narrow spinal structure's limited portion ofentire closure's surface area, higher moisture vapor transmission rateis possible over as much as 90 to 95 percent of the closure's total skincontacting and dressing overlapping surface area.

More particularly, a reinforced closure anchor in accordance with theinvention includes a first layer having an adhesive side, an oppositenon-adhesive side, and an outer edge. The reinforced closure anchor alsoincludes an anchor member layer having a reinforcing structure, anadhesive side, and an opposite non-adhesive side. The anchor memberadhesive side is adhered to the first layer non-adhesive side. Theanchor member may be generally centered between ends of the first layer,the anchor member may extend to portions of the outer edge of the firstlayer, and the anchor member may have a shape that generally correspondsin shape to a middle portion of the first layer.

The first layer may be a fabric layer, and the reinforced closure anchormay additionally include a film layer having an adhesive skin-adheringside and an opposite side adhered to the first layer adhesive side.Alternatively, the first layer may be a film layer. A release liner maybe releasably mounted on the adhesive side of the first (or “bottom”)layer.

A reinforced closure anchor in accordance with the invention includes afirst layer having an adhesive side, an opposite non-adhesive side, andan outer edge. The reinforced closure anchor also includes an anchormember layer having a reinforcing structure, a top side, and an oppositebottom side. The anchor member top side is adhered to the first layeradhesive side. The anchor member may be generally centered between endsof the first layer, the anchor member may extend to portions of theouter edge of the first layer, and the anchor member may have a shapethat generally corresponds in shape to a middle portion of the firstlayer.

The first layer may be a fabric layer, and the reinforced closure anchormay additionally include a film layer having an adhesive skin-adheringside and an opposite side adhered to the first layer adhesive side.Alternatively, the first layer may be a film layer. A release liner maybe releasably mounted on the adhesive side of the first (or “bottom”)layer.

These and other features and advantages of the invention will be morefully understood from the following detailed description of theinvention taken together with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a plan view of a reinforced closure anchor in accordance withthe invention;

FIG. 2 is an exploded view of the reinforced closure anchor of FIG. 1;

FIG. 3 is a cross-sectional view of the reinforced closure anchor takenalong the line 3-3 in FIG. 1;

FIG. 4 is an environmental view of the reinforced closure anchor of FIG.1 securing and stabilizing a dressing;

FIG. 5 is a plan view of a reinforced closure anchor in accordance withthe invention;

FIG. 6 is an exploded view of the reinforced closure anchor of FIG. 5;

FIG. 7 is a cross-sectional view of the reinforced closure anchor takenalong the line 7-7 in FIG. 5;

FIG. 8 is a plan view of a reinforced closure anchor in accordance withthe invention;

FIG. 9 is an exploded view of the reinforced closure anchor of FIG. 8;

FIG. 10 is a cross-sectional view of the reinforced closure anchor takenalong the line 10-10 in FIG. 8;

FIG. 11 is a plan view of a reinforced closure anchor in accordance withthe invention;

FIG. 12 is an exploded view of the reinforced closure anchor of FIG. 11;and

FIG. 13 is a cross-sectional view of the reinforced closure anchor takenalong the line 13-13 in FIG. 11.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings in detail, numeral 110 generally indicatesa reinforced closure anchor in accordance with the invention. Thereinforced closure anchor 110 may secure a portion of a medicaldressing, such as a portion at which medical tubing exits fromunderneath the dressing. The reinforced closure anchor 110 counteractstugging forces from any hemispherical vector direction that may beapplied on the medical tubing and helps prevent the tugging forces frompulling the dressing away from a patient's skin.

Turning to FIGS. 1 through 3, the reinforced closure anchor 110 includesa first layer 112 having an adhesive side 114 including an adhesive suchas a medical skin contact grade adhesive or similarly suitable adhesivethereon. The first layer 112 also has an opposite non-adhesive side 116and an outer edge 118. The first layer 112 is not limited to anyparticular shape. In the embodiment shown in the drawings, the firstlayer 112 is generally rectangular in shape with curved corners. Thefirst layer 112 may be made of a woven or non-woven fabric material.Alternatively, the first layer 112 may be made of a film such as apolyurethane film or similar.

An anchor member layer 120 including a reinforcing structure 122 isdisposed on a “top” side of the first layer 112. The anchor member 120may be made of a polypropylene or polyethylene net or net-like materialor another similar material, such as woven or non-woven or cellulosic orfoam or other laminar materials having sufficient non-elastic propertiesyet being flexible, “contourable” and permeable, and having rigidizingand force spreading properties as discussed below, wherein the nettingdefines the reinforcing structure 122. The anchor member 120 has anadhesive side 124 including a suitable adhesive thereon. The anchormember 120 also has an opposite non-adhesive side 126. The anchor memberadhesive side 124 is adhered to the first layer non-adhesive side 116.

The anchor member 120 is not limited to any particular shape, althoughthe anchor member typically has less surface area than the first layersuch that the anchor member only overlaps a portion of the first layer.For example, the anchor member 120 may have approximately half or lessthan half the surface area of the first layer 112. The anchor member 120is generally centered between ends of the first layer 112, and theanchor member has a shape that generally corresponds in shape to amiddle portion of the first layer. For example, the anchor member 120may extend to portions of the outer edge 118 of the first layer 112 andmay have a shape that corresponds to an entire middle ⅓ portion of thefirst layer.

The anchor member 120 strengthens the reinforced closure anchor 110 bymaking it less floppy for easier application. More importantly, as shownin FIG. 4, when the reinforced closure anchor 110 is applied over aportion of a dressing 150 and under the exiting tubing 152 (as well asto a patient's skin 154 where it is not over the dressing), the anchormember 120 spreads the localized external tubing tug forces that areexerted on the dressing 150 and the reinforced closure anchor 110 over alarge surface area, greatly increasing the dressing's resistance topremature separation from the patient's skin by not permitting thedressing to elongate and break the adhesive forces between the dressingand the patient's skin. Likewise, the anchor member 120 increases theamount of force necessary to separate the dressing 150, and thus thecatheter 156, from a patient's skin 154. With the use of the reinforcedclosure anchor 110, external forces exerted on a dressing are not aslocalized. Highly concentrated localized tug forces are a typical reasonsmall forces are able to commence peeling of a dressing by stretchingthe fabric and film of the dressing in a local area which thenpropagates onward. Commonly, forces external to the dressing are exertedon a dressing by pulling, snagging, or tugging on the IV connectorports, IV valves, pigtails, lumen, fittings, and/or medical fluidadministration tubing that are connected to a catheter underneath thedressing. For example, movement of the medical tubing may be caused bythe patient moving, by snagging of the tubing on other neighboringobjects, by a clinician moving the tubing or the patient, or anycombination of the above. The reinforced closure anchor 110 alsoprevents premature separation of a dressing from a patient's skin bypreventing the dressing from stretching and thus peeling when thedressing is tugged on as described above, for example, when the tubingconnected to the catheter hub is pulled. Stretching of a dressinglocally (and resultant peel propagation) can ultimately lead to adressing separating fully from a patient's skin. In sum, the reinforcedclosure anchor 110 greatly increases the withstand of a dressing andgreatly increases the amount of any hemispherical vectormulti-directional pulling force that is necessary to cause a dressing toseparate from a patient's skin. This leads directly to longer dwelltimes, better patient care, lower nursing time, and lower healthcarecosts.

The reinforced closure anchor 110 may be generally symmetrical about oneof its axes 128. A closure perforation line 130, for easy removal of theclosure anchor and associated dressing, may extend across the firstlayer 112 and the anchor member 120. In other words, the reinforcedclosure anchor 110 is perforated through all of layers (not includingany release liner layer(s)—see below) along the perforation line 130.The perforation line 130 may extend along the axis of symmetry 128,thereby dividing the reinforced closure anchor 110 into two mirror imageportions and allowing the reinforced closure anchor to be separated at adressing removal time while the closure anchor is still overlapped ontothe dressing on either side of the tubing. A V-shaped notch 132 may bedisposed along the first layer outer edge 118 at an end of theperforation line 130. The V-shaped notch 132 serves as a landmarkindicating where the perforation line 130 is located. A deep U-shapedrecess 134 is disposed along the first layer outer edge 118. TheU-shaped recess 134 may be at an opposite end of the perforation line130 relative to the V-shaped notch 132. When the reinforced closuremember 110 is applied to a dressing in an area where medical tubingexits from underneath the dressing, closure anchor's U-shaped recess 134is slid under the tubing and overlapped on top of the dressing behindthe catheter hub, creating opposing U-slot “keyholes” that the catheterhub cannot be easily tugged out of. The U-slot “keyholes” and the addedsurface area beyond the dressing's edge strengthen the dressing andgreatly increase the magnitude of a tug force necessary to raise thedressing's edge from a patient's skin, thereby improving securement andstabilization. The U-shaped recess 134 also makes it easier to create anocclusive barrier at the tubing exit point.

The reinforced closure anchor 110 may further include a release liner136 releasably mounted on the adhesive side 114 of the first layer 112.The release liner 136 may include a first member 138 and a second member140. The first member 138 includes a first portion 142 and a secondportion 144 and the second member 140 includes a first portion 146 and asecond portion 148. The first portions 142, 146 are mounted on the firstlayer adhesive side 114 and the second portions 144, 148 are foldedrelative to the first portions to form gripping tabs. The first member138 may overlap the second member 140, and each of the first and secondmembers may be released from the first layer adhesive side 114 withouttampering with the other of the members.

To apply the reinforced closure anchor 110, preferably only one of thefirst and second members 138, 140 of the release liner 136 is removed toexpose part of the first layer adhesive side 114. For example, the firstmember 138 may be removed by gripping the gripping tab 144 and pullingthe first member 138 away from the fabric layer adhesive side 114. Byleaving the second member 140 of the release liner 136 in place, a usermay grasp part of the reinforced closure anchor 110 without the user'sfingers becoming stuck to the reinforced closure anchor. Next, thereinforced closure anchor 110 is positioned where it is desired to applythe reinforced closure anchor 110. For example, the reinforced closureanchor 110 may be applied to an edge portion of a dressing at whichtubing exits from underneath the dressing. The reinforced closure anchor110 is positioned so that the closure anchor is under the tubing withthe U-shaped recess 134 laying on either side of the tubing andoverlapping the top surface of the dressing. The exposed first layeradhesive side 114 is then adhered to the outside of the dressing and anyportion of the patient's skin that is exposed underneath the reinforcedclosure anchor. Next, the second member 140 of the release liner 136 isremoved by pulling the gripping tab 148, and the rest of the reinforcedclosure anchor 110 is applied to the dressing and/or patient's skin.

Alternatively, the reinforced closure anchor 110 may be used in lieu oftape strips to secure medical tubing, such as IV tubing, to a patient'sskin.

To remove the closure anchor 110 and dressing from a patient's skin, theclosure anchor is separated along the perforation line 130 by tearingthe perforation line. The closure anchor 110 and dressing may then beremoved from the patient's skin as a single unit by pulling the closureanchor 110 and dressing away from the tubing and catheter hub, making itsafer and easier to remove the dressing from the tubing and hub with alowered risk of unwanted catheter movement.

In another embodiment, the reinforced closure anchor may further includeboth a fabric layer such as a woven or non-woven fabric or similar, anda film layer such as a polyurethane film or similar. As shown in FIGS.5-7, the reinforced closure anchor 210 includes a fabric layer 212 andan anchor member layer 220 including a reinforcing structure 222disposed on and adhered to a “top” non-adhesive side 216 of the fabriclayer 212. The fabric layer 212 and anchor member layer 220 may have anyof the features described in the previous embodiments. The reinforcedclosure anchor 210 further includes a film layer 260 having an adhesiveskin-adhering side 262. The adhesive on the skin-adhering side 262 maybe a medical skin contact grade adhesive or similarly suitable adhesive.A side of the film layer 260 opposite the skin-adhering side 262 isdisposed adjacent the fabric layer 212 and is adhered to the fabriclayer. A release liner 236 may be releasably mounted on theskin-adhering side 262 of the film layer 260. The film layer 260 mayhave a shape that is coincident with the fabric layer 212 and/or filmlayer 260. The film layer 260 may make the reinforced closure anchor 210more comfortable for a patient by shielding the fabric layer 212 fromthe patient's skin. The film layer 260 also can create a bacterialbarrier and can add stack strength to the closure anchor.

In this embodiment of the reinforced closure anchor 210, the anchormember layer 220 has the same size and shape as the anchor member layerin the first embodiment 110.

In yet another embodiment shown in FIGS. 8-11, the reinforced closureanchor 310 includes a first layer 312 having an adhesive side 314including an adhesive such as a medical skin contact grade adhesive orsimilarly suitable adhesive thereon. The first layer 312 also has anopposite non-adhesive side 316 and an outer edge 318. The first layer312 is not limited to any particular shape. In the embodiment shown inthe drawings, the first layer 312 is generally rectangular in shape withcurved corners. The first layer 312 may be made of a woven or non-wovenfabric material. Alternatively, the first layer 312 may be made of afilm such as a polyurethane film or similar.

An anchor member layer 320 including a reinforcing structure 322 isdisposed on a “bottom” side of the first layer 312. The anchor member320 may be made of a polypropylene or polyethylene net or net-likematerial or another similar material, such as woven or non-woven orcellulosic or foam or other laminar materials having sufficientnon-elastic properties yet being flexible, “contourable” and permeable,and having rigidizing and force spreading properties as discussed below,wherein the netting defines the reinforcing structure 322. The anchormember 320 has a first side 324 that is a “bottom” side and an oppositesecond side 326 that is a “top” side. The anchor member first side 324may include a suitable adhesive thereon. The anchor member 320 isdisposed within the outer edge 318 of the first layer 312. In contrastto the first embodiment 110, the anchor member “top” second side 326 isadhered to the first layer adhesive “bottom” side 314. Otherwise, thereinforced closure anchor 310 has similar features and functions as thefirst embodiment 110.

For example, the reinforced closure anchor 310 may be generallysymmetrical about one of its axes 328. A closure perforation line 330,for easy removal of the closure anchor and associated dressing, mayextend across the film layer 312 and the anchor member 320. In otherwords, the reinforced closure anchor 310 is perforated through all oflayers (not including any release liner layer(s)) along the perforationline 330. The perforation line 330 may extend along the axis of symmetry328, thereby dividing the reinforced closure anchor 310 into two mirrorimage portions and allowing the reinforced closure anchor to beseparated at a dressing removal time while the closure anchor is stilloverlapped onto the dressing on either side of the tubing. A V-shapednotch 332 may be disposed along the film layer outer edge 318 at an endof the perforation line 330. The V-shaped notch 332 serves as a landmarkindicating where the perforation line 330 is located. A deep U-shapedrecess 334 is disposed along the film layer outer edge 318. The U-shapedrecess 334 may be at an opposite end of the perforation line 330relative to the V-shaped notch 332. A release liner 336 may bereleasably mounted on the adhesive side 314 of the first layer 312. Therelease liner may have first and second members 338, 340.

The anchor member 320 is not limited to any particular shape, althoughthe anchor member typically has less surface area than the first layersuch that the anchor member only overlaps a portion of the first layer.For example, the anchor member 320 may have approximately half or lessthan half the surface area of the first layer 312. The anchor member 320is generally centered between ends of the first layer 312, and theanchor member has a shape that generally corresponds in shape to amiddle portion of the first layer. For example, the anchor member 320may extend to portions of the outer edge 318 of the first layer 312 andmay have a shape that corresponds to an entire middle ⅓ portion of thefirst layer.

In another embodiment, the reinforced closure anchor may further includeboth a fabric layer such as a woven or non-woven fabric or similar, anda film layer such as a polyurethane film or similar. As shown in FIGS.11-13, the reinforced closure anchor 410 includes a fabric layer 412 andan anchor member layer 420 including a reinforcing structure 422disposed on and adhered to a “bottom” adhesive side 414 of the fabriclayer 412. The fabric layer 412 and anchor member layer 420 may have anyof the features described in the previous embodiments. The reinforcedclosure anchor 410 further includes a film layer 460 having an adhesiveskin-adhering side 462. The adhesive on the skin-adhering side 462 maybe a medical skin contact grade adhesive or similarly suitable adhesive.A side of the film layer 460 opposite the skin-adhering side 462 isdisposed adjacent the fabric layer 412 and is adhered to the fabriclayer. A release liner 436 having first and second members 438, 440 maybe releasably mounted on the skin-adhering side 462 of the film layer460. The film layer 460 may have a shape that is coincident with thefabric layer 412 and/or film layer 460. The film layer 460 may make thereinforced closure anchor 410 more comfortable for a patient byshielding the fabric layer 412 and the anchor member layer 420 from thepatient's skin. The film layer 460 also can create a bacterial barrierand can add stack strength to the closure anchor.

In this embodiment of the reinforced closure anchor 410, the anchormember layer 420 has the same size and shape as the anchor member layerin the third embodiment 310.

Although the invention has been described by reference to specificembodiments, it should be understood that numerous changes may be madewithin the spirit and scope of the inventive concepts described.Accordingly, it is intended that the invention not be limited to thedescribed embodiments, but that it have the full scope defined by thelanguage of the following claims.

1. A reinforced closure anchor comprising: a first layer having anadhesive side, an opposite non-adhesive side, and an outer edge; and ananchor member layer having a reinforcing structure, an adhesive side,and an opposite non-adhesive side, said anchor member adhesive sidebeing adhered to said first layer non-adhesive side; said anchor memberbeing generally centered between ends of said first layer, said anchormember extending to portions of said outer edge of said first layer, andsaid anchor member having a shape that generally corresponds in shape toa middle portion of said first layer.
 2. The reinforced closure anchorof claim 1, wherein said first layer is a fabric layer.
 3. Thereinforced closure anchor of claim 2, including a film layer having anadhesive skin-adhering side and an opposite side adhered to said fabriclayer adhesive side.
 4. The reinforced closure anchor of claim 1,wherein said first layer is a film layer.
 5. The reinforced closureanchor of claim 1, including a release liner releasably mounted on theadhesive side of said first layer.
 6. The reinforced closure anchor ofclaim 3, including a release liner releasably mounted on the adhesiveside of said film layer.
 7. A reinforced closure anchor comprising: afirst layer having an adhesive side, an opposite non-adhesive side, andan outer edge; and an anchor member layer having a reinforcingstructure, a top side, and an opposite bottom side, said anchor membertop side being adhered to said first layer adhesive side; said anchormember being generally centered between ends of said first layer, saidanchor member extending to portions of said outer edge of said firstlayer, and said anchor member having a shape that generally correspondsin shape to a middle portion of said first layer.
 8. The reinforcedclosure anchor of claim 7, wherein said first layer is a fabric layer.9. The reinforced closure anchor of claim 8, including a film layerhaving an adhesive skin-adhering side and an opposite side adhered tosaid fabric layer adhesive side.
 10. The reinforced closure anchor ofclaim 7, wherein said first layer is a film layer.
 11. The reinforcedclosure anchor of claim 7, including a release liner releasably mountedon the adhesive side of said first layer.
 12. The reinforced closureanchor of claim 10, including a release liner releasably mounted on theadhesive side of said film layer.